Registration Dossier

Administrative data

Description of key information

Two dietary 90 -day studies are available, one in rats and one in dogs.

Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
627 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In a subchronic study in rats, a NOAEL of 627 mg piperazine base/kg bw/day has been established based on reduced body weight gain observed at the next higher level tested. In a subchronic study in dogs the NOAEL was set at the highest level tested as no treatment-related changes were observed; this NOAEL was at least 25 mg piperazine base/kg bw/day during the first 5 weeks of the study, and at least 60 mg/kg bw/day during week 6 -13 of the study.

Justification for classification or non-classification

In view of the NOAEL of 627 mg piperazine base/kg bw/day in rats and the NOAEL of at least 25/60 mg piperazine base/kg bw/day in dogs in 90 -day studies, there is no need to classify piperazine for STOT Repeated Exposure.